This invention relates to a device for attaching a portion of the tube or conduit portion of a catheter to the human body by use of a rotatable disk, which has at least one catheter tube retaining channel, attached to a base member.
Catheters are common devices employed in a variety of medical procedures. In general, catheters are defined as tubular medical devices for insertion into a canal, blood vessel, passageway or body cavity usually to permit the injection or withdrawal of fluids, to promote drainage, and/or to keep the passageway open. Some catheters include needle portions, others do not.
A portion of a conventional catheter 10 is seen in FIG. 1. One end of catheter 10 (not shown) which has one or more holes therein, is inserted into the human body while the other end of the catheter includes at least one tube opening 11 for drainage. Depending upon the medical procedure desired, catheter 10 may have one or more additional tube openings, such as illustrated at 13. In this configuration, tube opening 13 is used to inject a fluid (usually sterile water) into a conventional catheter balloon portion (not shown) for inflation of the balloon after the balloon has been inserted into a body cavity, such as a bladder. Tube opening 11 provides the pathway for withdrawal of body fluids, such as urine. Other tube openings (not shown) on catheter 10 can also be employed, such as to inject antibiotics for flushing out the body cavity or sterile fluid. Catheters of various diameter or sizes (e.g. 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 and 28) are commonly used with adults.
Catheters are usually manufactured from latex, polyurethane or rubber, but can be manufactured from other materials. For example, silicon catheters are useful for extended medical treatments, while rigid catheters are made for insertion into small children and babies. Because of their widespread use in varying medical procedures, several types of catheters exist which are manufactured for specialized medical procedures. For example, cardiac catheters include a flexible tube with a balloon-like tip that is threaded into a patient's coronary arteries during an angioplasty procedure and then inflated to flatten material that is clogging the arteries and obstructing blood flow. Similarly, catheters can also be used for alveolar lavage in respiratory disease therapy, while other types of catheters include, but are not limited to, rectal catheters, nasal catheters, epidural catheters and intravascular ultrasound (IVUS) catheters. Finally, catheters for urological or incontinence purpose (known as "foley" catheters) are also commonly known. There are several manufacturers of catheters, including Trek Medical of Tampa, Florida, Baxter Healthcare Corporation of McGaw Park, Ill., C. R. Bard of Covington, Ga. and Abbott Labs of North Chicago, Ill.
The term catheter is also applied to intravenous tubes ("IV tubes") which are typically used to permit the injection or withdrawal of fluids from the body. Similarly, several medical techniques incorporate electrical signal wire similar to a catheter's use, as such wires can be useful for stimulating (e.g., injecting) or monitoring (e.g., withdrawing) information from the human body.
After a catheter is inserted in the human body, the portion of the catheter which is external to the body is usually attached to the body at one or more locations. This is a recommended procedure for several reasons. First, because the catheter is usually directly coupled to a human cavity (e.g., such as a heart, vein or a bladder), any movement of the catheter near its entrance to the body may also result in movement of the catheter within the body. If the movement is continuous or repetitive, this will likely result in irritation to the body cavity and potentially result in infection. Second, several forms of catheters utilize a balloon to retain one end of the catheter in the body cavity. As the catheter moves external to the body, the balloon similarly moves, resulting in friction between the tissue of the body cavity and the balloon. If this friction continues, the cavity tissue may begin to bleed. This is a common occurrence in urinary catheters, as blood frequently is found in urinary bags which are attached to a urinary catheter. It is believed that some, if not all, of this blood is the result of the friction between the catheter and the urinary tract/interior bladder surface.
Several methods exist for attaching the catheter to the body. For example, if the catheter is employed for incontinence or urological purposes, the catheter tube can be placed on men either on the inner or outer thigh through the use of adhesive tape, while in women, catheters are generally placed on the inner thigh. When attached to the human leg by adhesive tape, the catheter is initially snugly affixed between the leg and the adhesive tape. However, as a person continues to move in a natural manner, the tape adhesive loses its adhesion to the catheter, but generally remains adhesive to the human skin. In this situation, the catheter is no longer snugly fit between the tape and the skin, and begins to rub against the skin or body hair thereby irritating the skin. Naturally, this condition can be extremely painful to the patient, and can also result in infection if not properly treated.
In other applications, the catheter portion extending from the body can also be attached to the body by means of a conventional rubber or Velcro strap. These types of straps are usually included with smaller incontinence bags which are used by patients with a urological catheter when traveling. While flexible, these types of straps are not effective at retaining the catheter in a stable position relative to body movement. For example, these straps, if not wrapped around the body properly, tend to slip off the body as it moves. Conversely, if the strap is too tight, it tends to irritate the skin whether or not the body moves, and could lead to infection of the skin. Further, if the strap is worn, old or contains a manufacturing defect, it could break, thereby allowing the catheter to freely swing without any retention to the body.
Finally, in some applications, catheters are purposely not attached to the body, but are allowed to freely swing. This is rarely a recommended procedure, as catheters such as IV tubes, can easily be displaced from the human body as it moves. Additionally, the freely swinging catheter can be unintentionally moved (such as during sleep) so as to result in extreme irritation and severe pain to the patient.
There are also well-known, severe problems associated with catheters' ripping out of patients when catheter tubes accidentally are caught on obstructions during patient transport causing injury and bleeding. Similarly, catheters can be ripped out, yanked out or otherwise cause injury when patients are walking and they step on the catheter tube.
Several other known problems exist in using catheters not related to their attachment to the body. For example, because catheters are typically constructed from pliable material, they tend to kink when bent beyond 45 degrees, thereby resulting in blockage of the catheter. When kinking occurs in urology catheters, fluid pressure within the bladder increases to the point that the fluid eventually seeps out of the human body resulting in an uncontrolled leakage. Further, this type of situation is likely to occur when a patient is asleep because as the patient normally moves throughout the night, the catheter similarly moves. If the catheter moves so as to bend beyond 45 degrees, it will likely block the fluid passage.
If catheter movement during normal body movement can be reduced and/or eliminated, it is believed that infection rates can be drastically reduced. Clearly, a need exists for retaining the external portion of the catheter in a stable position relative to the body during normal movement, to prevent irritation and pain from both the internal and external portions of the human body.
Catheter needle locating devices are disclosed in U.S. Pat. Nos. 4,585,443 and 4,666,434, both issued to J. M. Kaufman. Kaufman '443 discloses a device for securing catheter needles to grafts and the like implanted in patients, primarily for use in connection with dialysis treatment. The device includes an anchoring bracelet for attachment to the patient at a predetermined location at which the graft is located, and a rotatable saddle mounted in the anchoring bracelet, which saddle includes an aperture adapted to receive the needle portion of the catheter. The device also includes a contact surface having a shape adapted to mate with the graft, and a saddle channel extending between the aperture and the contact surface, so that the needle projects a predetermined distance from the contact surface when it has been inserted into the aperture, thereby permitting the needle to be accurately located in the graft and firmly anchored on the patient. In particular, when the device has been applied to the patient, as shown in FIG. 1 of Kaufman '443, the axis of rotation of the saddle will be perpendicular to the patient's skin. Thus, after application of the device to the patient, but prior to insertion of the needle, fine alignment between the needle and the graft can be affected by rotation of the saddle about its axis of rotation by a small degree. Similarly, Kaufman '434 discloses a device for securing catheter needles to grafts implanted in patients.
Accordingly, it is an object of the present invention to provide a catheter tube retaining device for use with a catheter tube, an IV tube, and electrical signal wires or like tubular structures, capable of retaining a portion of the tube or conduit portion of a catheter while simultaneously allowing rotational movement relative to the body as the body moves.
It is also an object of the present invention to provide a catheter tube retaining device having a base, a rotatable disk having at least one channel (or equivalent) for retaining a portion of the tube or conduit portion of a catheter and a pin attaching the base to the disk, to retain such portion of the catheter tube in a stable but rotatable position relative to the human body which results in minimal or no movement of the internal portion of the catheter.
It is a further object of the present invention to provide a catheter retaining device having a base and an attached rotatable disk having at least one channel (or equivalent) for retaining a portion of the tube or conduit portion of a catheter to prevent an external portion of such catheter tube from bending beyond a 45 degree angle, to thereby prevent tube kinking or blockage.
This invention improves both catheter use and safety, and further alleviates or reduces any patient irritation or pain associated with using a catheter.